Baxter Colleague 3 and 3 CX Infusion Pumps, Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Med

FDA device recall Z-2796-2011 · posted 2011-07-13 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

The Air In Line (AIL) test was not properly performed by the service technician at the Service Center.

Action taken

Baxter telephoned all seven affected customers beginning May 4, 2011, informing them that that a post repair test was not performed correctly on their Colleague pumps during the last service. As a result, the device Air Sensor may not function as designed and could lead to undetected air in the IV line. Baxter wants to ensure that the devices are properly tested, safe and effective. Baxter requested that they locate the pumps and remove them from use as soon as possible. Baxter will coordinate with the affected customers, the return of the device for the necessary testing to be completed at their facility and return of the device back to the customer at no cost. Please call ( 800 ) 437-5176 for a complaint that includes any indication of the failure of the product to meet a customer's expectations for quality or to meet performance specifications.

Root cause

Employee error

Status

Terminated

Product code

FRN

Quantity affected

12 pumps

Distribution

Nationwide Distribution including the states of NY, Oh, KY,SC, PA, FL and Puerto Rico.

Date initiated

2011-05-04

Date posted

2011-07-13

Date terminated

2017-01-10

Location

Round Lake, IL

Related 510(k) clearances